To apply for Class C medical device registration with the Health Sciences Authority (HSA) in Singapore, you will need to use the HSA’s online Medical Device Registration (MDR) portal. Here's how you can apply:

Steps to Apply for Class C Medical Device Registration with HSA:

1. Visit the HSA MDR Portal:

   • The portal for medical device registration is available on the official HSA website. The direct link to the portal is:
     • HSA Medical Device Registration Portal

2. Create an Account:

   • If you don't already have an account, you will need to create one. This is required to access the portal and submit your application.
   • You will be required to provide details such as your company name, contact information, and other relevant details.

3. Log in to the Portal:

   • After creating your account, log in to the portal with your credentials.

4. Complete the Registration Application:

   • Select the appropriate type of application for Class C medical devices.
   • Fill out the registration application form with necessary information about the device, its intended use, manufacturer, and other relevant details.

5. Upload Required Documentation:

   • Upload all the required documentation, including:
     • Device information (description, technical specifications, and labeling).
     • Manufacturing information (evidence of Good Manufacturing Practices, ISO certifications, etc.).
     • Clinical data (if required).
     • Risk management documents.
     • Quality management system certifications (such as ISO 13485).

6. Pay Registration Fees:

   • After completing the application, you will need to pay the required registration fees (typically between SGD 3,000 to SGD 5,000 for Class C devices).

7. Submit the Application:

   • After completing the form and paying the fees, you can submit the application electronically through the portal.

Important Information:

• Local Authorized Representative (LAR): If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) based in Singapore to submit the registration on your behalf.
• Application Status: You can track the status of your application through the portal.

If you need more details on specific steps or have additional questions about the application, feel free to ask!

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